MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 41 MM STD; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74024841
Health Effect - Clinical Code	Septic Shock (2068)
Date of Event	02/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision of right knee patella when the reported device was implanted ((b)(6) 2015) was reported on 1020279-2017-00692.The same procedure (b)(6) 2015 patient was implanted with zimmer 5876-10-19 patellar component.Other aes for this patient have been reported under 1020279-2017-00690 and 1020279-2017-00694.
Event or Problem Description
It was reported that patient was presented to emergency room with left leg swelling including calf, knee and thigh associated with warmness, hotness to swelling area and increasing pain - pain severe ache and throbbing.Also complains of chills light headiness and nausea and mild sob with exertion.Patient was found to have patellar approx one month ago.Event was marked as: cellulitis and hematoma systemic inflammatory response syndrome/sepsis.The event is marked at resolved on (b)(6) 2016.
Additional Manufacturer Narrative
Correction based on event clarification received.Two devices reported with therapy dates (b)(6) 2015 have been implanted in (b)(6) 2015 in patient's anatomy contraleral of swelling.
Additional Manufacturer Narrative
It was reported that event communicated through this mdr is in relation to patellar fracture which was communicated through mdr 1020279-2017-00694.

• Brand Name: JRNY BCS PAT RESRF RD 41 MM STD
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6840875
• Report Number: 1020279-2017-00695
• Device Sequence Number: 659438
• Product Code: JWH
• UDI-Device Identifier: 00885556179918
• UDI-Public: 00885556179918
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2023
• Device Catalogue Number: 74024841
• Device Lot Number: 12MM10437
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 09/05/2017; 10/13/2017; 10/13/2017
• Initial Report FDA Received Date: 09/04/2017
• Supplement Report FDA Received Date: 09/26/2017; 11/01/2017; 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 108